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NCT04835168 Clinical Trial

Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04835168
Other study ID # BT-11-EoE
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 30, 2022
Est. completion date June 30, 2022

Study information
Verified date June 2023
Source NImmune Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility No patients enrolled

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BT-11 low
Oral
• BT-11 high
Oral
• Placebo
Oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NImmune Biopharma

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and severity of AEs 12 Weeks
See also
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